Integrated fluid module and test device

ABSTRACT

An integrated testing device and fluid module are disclosed, as well as a method of manufacture. Fluid module contains a reservoir containing a test fluid, and a control vessel. The reservoir discharges test fluid into the control vessel, which discharges the test fluid in a controlled way to a test component.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a divisional of U.S. patent application Ser. No.16/348,979, entitled INTEGRATED FLUID MODULE AND TEST DEVICE, filed onMay 10, 2019, which claims priority to International Patent ApplicationNo. PCT/AU2016/05, filed on Nov. 21, 2016, which claims priority toAustralian Patent Application No. 2016904609, filed on Nov. 11, 2016,the entirety of which is incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to devices and methods for providing testswhich require a test fluid, and to devices and packages which facilitatesuch testing.

BACKGROUND OF THE INVENTION

Various kinds of tests, for example medical tests, assays and industrialtests, are performed which enable a relatively rapid outcome to beobtained at the point of testing. These may be, for example, home tests,point of care tests, or used in laboratories, pathology clinics orhospitals.

Performing these relatively rapid tests can require complicatedinstructions and multiple devices and components to be used. The presentinvention is not concerned with the specific chemical or biochemicaltests to be performed, but rather with the devices, fluid delivery andassociated mechanical systems which house and contain the testcomponents. For example, in a medical context, such devices and systemsmay be used with a lateral flow or other type of rapid test.

In a typical conventional home or point of care blood test, for example,the user is presented with a collection of components, including thetest device itself, a separate lancet, blood collection receptacles, acontainer of buffer or other test fluid, an adhesive bandage, cleaningwipes, and possibly further components. The user is expected to follow avery precise sequence of steps, typically including cleaning the site,operating the lancet, obtaining a blood sample of a known volume anddelivering it to the precise place required, applying a buffer solutionat the right time and place and at the correct volume and rate, readingthe test result and interpreting the outcome.

Many tests are performed either as infrequent or one off procedures, sothat the user does not become proficient through regular use. Proceduresperformed at point of care are carried out generally by skilledoperators, but again the complexity and dexterity required to carry outthe test accurately presents a challenge and specific tests may beperformed infrequently. In such situations it would be advantageous ifthe test device could better facilitate simple, reliable and accurateoperation.

In PCT application numbers PCT/AU2011/000315 and PCT/AU2011/022321, thedisclosures of which are incorporated by reference herein, the presentapplicant has disclosed integrated testing devices. In particular, thosedevices may include a reservoir or sachet of a physiologicallyacceptable fluid, such as a buffer. For many tests, for example certainblood tests, it is required that a buffer or other reagent is applied tothe test material after the blood sample, in order to achieve a validresult or to achieve the result within an acceptable timeframe. Thedevices disclosed in embodiments of these disclosures permit the user todischarge a fluid, illustratively a buffer, from the internal reservoironto the test material.

PCT publication No. WO2015075677, the disclosure of which is herebyincorporated by reference, discloses test devices and methods, in whicha reservoir within the test device discharges into a control vessel, sothat the rate of delivery of fluid to a test material is controlled.

It is an object of the present invention to provide a test device, fluiddelivery module and method which improve the delivery of fluids to atest material.

SUMMARY OF THE INVENTION

In a broad form, the present invention provides an integrated packagefor delivering a test fluid, and a process for forming such a package.

According to one aspect, the present invention provides a process forforming a liquid filled reservoir with a frangible seal, the frangibleseal being across a fluid conduit extending from a liquid filledreservoir, the process including the steps of: forming a reservoir body;filling the reservoir body with a liquid; positioning a base componenton the reservoir body and using a set of first tools to heat seal thebase component to the reservoir body, so as to create a fluid tight sealaround the reservoir body, apart from a conduit; and using a set ofsecond tools to heat seal across the conduit, wherein the heat appliedby the second tool creates a frangible seal across the conduit.

The invention further includes a fluid filled module formed by the aboveprocess.

According to another aspect, the present invention provides Anintegrated testing device including: a test component; a test fluidmodule, including a reservoir containing a test fluid, a deliveryvessel, and a conduit connecting the reservoir and the delivery vessel;and a fluid delivery actuator, wherein operation of the fluid deliveryactuator causes the test fluid to be released from the reservoir intothe delivery vessel, the delivery vessel being adapted to provide acontrolled discharge of test fluid onto the test component.

According to a further aspect, the present invention provides a methodfor delivered a test fluid for an integrated test, including at leastthe steps of: providing a test unit including a test component, a fluidmodule having a reservoir containing a test fluid, a delivery vessel,and a conduit connecting the reservoir and the delivery vessel, and afluid delivery actuator; operating the fluid delivery actuator andthereby exerting a pressure on the reservoir; releasing the fluid intothe delivery vessel as a result of the pressure on the reservoir;thereby providing a controlled release of fluid from the delivery vesselonto the test component.

Implementations of the present invention can also, allow for differentrates of release, simply by varying the size and/or shape of the openingin the vessel. The fluid may be released directly from the controlvessel onto the test component, or via a conduit or channel.

The term ‘controlled discharge’ throughout the description and claimsrefers to releasing the fluid from the vessel in a way which is morecontrolled in flow rate than simply releasing the full contents of thesachet in a single burst. It may, in one form, merely amount to slowingdown the rate of flow. It may in other forms more closely control therate of discharge and adapt it closely to the requirements of the test.In many forms, the discharge rate will not be constant.

Implementations of the present invention accordingly allow for aconvenient, accurate and practical fluid delivery module, for use inintegrated testing and in other applications.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present invention will now be describedwith reference to the accompanying drawings, in which:

FIG. 1 shows an isometric view of an implementation of the presentinvention, without the lancet activated;

FIG. 2 is a view in section of an implementation in a first position;

FIG. 3 is a view in section of an implementation in a second position;

FIG. 4 is a view in section of an implementation in a third position;

FIG. 5 is an isometric view of a blood collection arm according to oneimplementation;

FIG. 6 is a plan view, with the upper section removed, of theimplementation of FIG. 1 ;

FIG. 6A illustrates the situation after the depressible portion has beenactuated;

FIGS. 7A, 7B and 7C are detailed sections illustrating fluid movementwithin an implementation of the device;

FIG. 8 illustrates an implementation of the package in a filled state;

FIG. 9 illustrates an implementation of the package in an emptied state;

FIG. 10 is a detailed view illustrating the relationship between thewell and the test strip in one implementation;

FIG. 11 illustrates the components of an implementation of the package;

FIG. 12 illustrates a first stage in production of an implementation ofa package;

FIG. 13 illustrates the unsealed are resulting from FIG. 12 ;

FIG. 14 illustrates a second stage in the production of animplementation of a package;

FIG. 15 illustrates notional tools for heat sealing the implementationof FIG. 12 in the first stage of sealing;

FIG. 16 illustrates notional tools for heat sealing the implementationof FIG. 14 in the second stage of production; and

FIGS. 17A, 17B, 17C illustrate the interlock mechanism according to oneimplementation of the present invention; and

FIGS. 18A, 18B and 18C are sectional views illustrating the formation ofthe frangible seal.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will be described with reference to a number ofpossible embodiments. It will be appreciated that the present inventionis capable of being implemented in numerous ways, in addition to theexamples provided. The embodiments are intended as illustrative, and arein no way limitative of the inventive concept or its possibleimplementations. Further, it will be understood that the features ofdifferent embodiments may be formed into different combinations, oradded together, in order to provide further implementations of thepresent invention.

The present invention is principally concerned with a specific aspect ofthe operation of a test device, relating to the discharge of a fluidwhich is intended to contact the test material, and to the manufactureand construction for a module for discharging a test fluid. Accordingly,while specific examples of the remaining mechanical structures of a testunit will be provided and described, it will be understood that inprinciple the present invention can be used with any design of such atest unit. In particular, known test units, as well as those disclosedin the specifications incorporated by reference, may be modified so asto incorporate implementations of the present invention.

Whilst the invention will be principally described with reference to amedical application, it will be appreciated that the present inventioncan be applied to many other forms of industrial or laboratory tests, inwhich a test fluid must be added to a test material, or test sample,prior to a result being determined. Other examples of possibleapplications include environmental testing, biosecurity, food safety,testing for illicit drugs, and veterinary medicine.

FIGS. 1 and 2 illustrate one implementation of the present invention, incross section in FIG. 2 . The test unit 10 includes a cover 15, whichincludes a depressible portion 26 for releasing the test fluid 41. Testfluid 41 is contained in a package 40. Test unit 10 further includes anarm 25 with a collection device 28 for a bodily fluid, in this caseblood. Test unit 10 also has an opening 20 for a blood sample to bereceived, and an indicator opening 21, through which the result of thetest can be seen.

Package 40 includes a fluid reservoir 43 containing test fluid 41, afrangible seal 55, and a well 50.

As will be described in more detail below, in use, the operatoraccording to this embodiment operates lancet 30 to release blood from asuitable site on the body, for example a finger. In this implementationlancet 30 is integrated with the unit, although in other implementationsit could be a separately supplied device. Lancet 30 is spring loaded andonce actuated will penetrate the user's finger. The user may need tomilk the blood from the lanced site in order to provide a sufficientsample

In FIG. 2 , lancet 30 is ready for use, once the cover 31 is removed. InFIG. 3 , lancet 30 has been operated and is then withdrawn within body10 (for safety). The device is now ready for collection of blood.Collection device 28 is placed onto the exuded blood, and withdraws (inthis case by capillary action) a sample. Other sample collectionarrangements may be used in alternative implementations, for example anon-integral suction or capillary device, or direct placement of thefluid onto the test material 60. In the illustrated arrangement,collection device 28 will retain only the required volume of blood.

After the collecting device is filled, the arm 25 may then be rotated(as will be described in more detail below) into a delivery position.The collection device is then in contact, via opening 20, with testmaterial 60, and the sample is discharged onto test material 60. This isshown in FIG. 4 .

The user may then depress section 26, which applies a force to package40 so that the pressure in fluid reservoir 43 is increased sufficientlythat frangible seal 55 fails and allows test fluid 41 to be released andflow into well 50. Well 50 has one or more openings (not shown in theseviews) which allow test fluid 41 to discharge at a controlled rate ontotest material 60.

It is emphasised that the present invention can be applied to any kindof test, in to control the rate of test fluid introduction to the testmaterial. In this case, the test is illustratively a lateral flow test.However, any other desired type of desired type of immunoassay,chromatographic assay, DNA assay, enzymatic assay, or other test may beused. The test may be an or use an electronic, optical or other sensor,as well as or in place of the lateral flow or similar test. The test maybe read by the operator, or interpreted with an electronic or otherautomated system. Similarly, the test fluid may be water, a buffersolution, or any other required fluid to conduct, support or beotherwise used in conjunction with the test.

It is In other implementations, the fluid may mix with the sample to betested prior to introduction to the test material. It will equally beunderstood that while the implementations illustrated show the uses of asingle package. In other implementations multiple packages may bepresent, for example to perform multiple tests in a single unit. In yetother implementations, the package may discharge from the well onto morethan one test material, for example using separate discharge openings.

FIG. 5 illustrates in more detail the arm 25 and associated structures.In the illustrated implementation, the arm 25 operates as an interlockto prevent the delivery of test fluid 41 onto test material 60 until thearm 25 has rotated into the delivery position.

In FIG. 5 , cams 32, 32A can be seen. The rotational positon of cams 32,32A determines whether the fluid in the reservoir can be released, viaengagements with corresponding parts of the depressible portion 26.

In FIG. 17A, the lancet 30 is in a rest position, and so no blood hasyet been drawn. Projection 33 on depressible portion 26 is engaged bycam 32, and cannot move downwards. In FIG. 17B, the lancet 30 has beenengaged and operated, and has moved to a safe rest position 31. Bloodcan now be collected in collection device 28. Cam 32 still blocksprojection 33.

In FIG. 17C, arm 25 has been rotated, so that blood can be depositedonto the test material 60 via opening 20. Cam 32 has now rotated so thatrecess 34 is located adjacent projection 33, and the depressible portion26 can now be moved downward, so as to exert pressure on package 40 andrelease the fluid (not shown in this view). Thus, cam 32 acts as aninterlock to prevent premature release of the test fluid. It will beappreciated that other mechanical system could be used to achieve this.Examples of such mechanisms are provided in the applicant's patentapplications referenced above. In many cases, the timing of the deliveryof the fluid is critical to a proper result, and premature release willinvalidate the test.

The operation of the overall system, and its discharge, can be betterunderstood from FIG. 6 and FIGS. 7A, 7B and 7C. FIG. 6 is a plan view,partly in section, so that the arrangement of the components in thefluid flow path can be better understood. Package 40 can be seen, thefluid reservoir 43 containing test fluid 41. Fluid reservoir 43 connectsto well 50 through discharge conduit 52, which is initially blocked byfrangible seal 55. When sufficient force is applied by depressibleportion 26 to fluid reservoir 43, the frangible seal fails, fluid flowsthrough the discharge conduit 52 into well 50. Well 50 includes a outlet51. In this implementation, outlet 51 discharges directly onto area 61of the test material 60. Referring to FIG. 4 , it can be seen that thebuffer is in this implementation discharged at point 61 so that it willpass through the area 62 where the blood sample has been deposited, soas to facilitate the test. However, it will be appreciated that bysuitable relative positioning, different ordering and positioning of thetest fluid and sample may be provided.

FIGS. 7A, 7B and 7C illustrate in more detail the sequence of test fluiddischarge in the illustrative device.

In FIG. 7A, the fluid delivery reservoir 43 contains the test fluid 41and has yet to be discharged by pressure from depressible portion 26.This is the condition in which the test device is supplied, and in thisstate, test fluid 41 is completely sealed by frangible seal 55 withinthe fluid delivery reservoir, thereby maintaining a desired compositionand condition of the test fluid.

In FIG. 7B, depressible portion 26 has been depressed, so that the fluidreservoir 43 has been effectively emptied through conduit 52 and testfluid 41 is being discharged (as illustrated by the arrow 57) into well50. Well 50 is directly engaged with test material 60 at area 61. Itwill be appreciated that in other implementations, different fluid flowpaths and geometry could be employed.

However, it has been determined by the inventors that using a directdischarge and minimising the intervening fluid paths minimises thevolume of fluid which remains in the fluid path, through surfaceeffects, surface tension, and other fluidic adherence to the surfaces inthe fluid path. Whilst this is not essential, minimising these lossespermits a more accurate volume of test fluid to be delivered, andminuses waste.

In FIG. 7C, the test fluid 41 is discharging in a controlled way throughopening 51 onto test component 60. Thus, test fluid 41 is discharged ina measured, controlled way onto test component 60 and not in anuncontained rush. Thus, well 50 acts as a control vessel, and allows forthe rate of flow of test fluid 41 to be controlled.

It will be understood that while the fluid will discharge over time, itwill not necessarily be at a constant rate. The rate will be determinedin part by the sizes of the opening (or openings) in the well, as wellas the absorption by the test material. Flow may slow as more or most ofthe fluid has left the vessel, for example.

It has been determined by the inventors in preferred implementations, itis advantageous for the volume of the well to be smaller than the thanthe volume of the fluid reservoir. This allows of the depression of thedepressible portion 26 to exert force over a period of time, so as toprovide a positive pressure from the fluid 41 in the fluid reservoir 43,through well 50, outlet 51, and into the test material at area 61. Thisin turn provides for a consistent flow of test fluid 41 into the testmaterial 60. This also more positively forces the fluid into the testmaterial. Test material 60 in this implementation draws test fluid 41into and along the test material 60, by capillary action, so thatfurther fluid can be drawn in from well 50 and ultimately from reservoir43.

It will also be understood that the fluid should contact the testmaterial as directly as possible, and that it is desirable that thevolume of test fluid 41 can be controlled to provide consistent deliveryvolumes, as well as a consistent and correct total volume delivered.This is facilitated by the volume of well 50 being smaller than thevolume of reservoir 43. As will be described in more detail below withreference to FIG. 11 , a vent opening 111 is advantageously provided inthe seal over well 50, 102. If no vent is provided, air cannot enter toreplace the test fluid 41 as it is dispensed onto test material 60. Thisin turn may create a pressure lock, preventing or impeding the passageof test fluid 41 onto test material 60, or fluid delivered outside ofthe test material due to pressure build up behind the delivered fluid,exiting the well.

Vent opening 111 also assists in another respect. In some circumstancesthe user may apply pressure sufficient to excessively compress reservoir43. This can then result in an uncontrolled rapid burst of fluid‘exploding’ inside teste unit 10, so the fluid is delivered to theinterior in general and not in the desired controlled way to the testmaterial 60. Vent opening 111 in this case provides a way for excessfluid pressure to vent, without the whole fluid reservoir 43 failing.

To facilitate the flow, it is advantageous that is there is a good fluidengagement between the outlet 51 and area 62. If the engagement isloose, then test fluid 41 may be discharged within the device but not ontest material which is undesirable.

In this implementation, a further feature is that an interlock isprovide between the depressible portion 26 and the test unit, so thatonce actuated the depressible portion stays in the depressed positionand the reservoir 43 compressed.

Referring first to FIG. 4 , the test strip unit 10 incudes a frontprojection 36. This is located just in front of the depressible portion26. Depressible portion 26 also includes a lower projection 37 with afoot 38 at the base, and angled face 39.

FIG. 6A illustrates the situation after the depressible portion 26 hasbeen actuated. The fluid has been forced, or is in the process of beingforced, from reservoir 43 into well 50. Foot 38 has been forced past thetop edge of projection 36, and projection 36 now engages angled face 39.Thus, depressible portion 26 is now retained in the depressed state,thereby maintaining pressure on reservoir 43. This retention alsoprevents any chance that fluid could return into the reservoir, or thatthe force to maintain pressure on the reservoir and hence force fluidthrough well 50 and into test material 60 will not be maintained. Assuch, this interlock feature assists in ensuring controlled delivery offluid to the test material 60.

Further, it is desirable that there be as little air within the fluidreservoir as possible. This allows for the force applied by the user viadepressible portion 26 to act directly on the test fluid, whendepressible portion 26 is engaged, rather than first compressing airwithin the package 40. Reducing the air content inside the sealedreservoir 43 reduces the burst force which the use needs to apply torelease test fluid 41. A smaller burst force is desirable from ausability perspective, as it is easier for the user to operate andcontrol. A larger burst force means that the user has to press harderwhich may be physically difficult in some cases, as well as increasingthe risk of inadvertent damage to the test unit, or uncontrolled testfluid discharge due to excessive force, This similarly allows for morereliable operation of the package, and thus the overall device.

The fluid in the sachet may be any kind of fluid necessary or desired toperform, assist or validate the test. It will be appreciated that thefluid may have different properties, for example density, viscosity andsurface tension, and that appropriate changes to the package may need tobe made. The present invention is concerned with how the fluid isdelivered, and is applicable to any desired fluid for use with a test.

The test material may be, illustratively, a lateral flow test for acomponent of blood, electrolyte, blood sugar, cholesterol or any otherblood component. It may adapted to detect specific biological orimmunological responses, for example the presence of a pathogen orantibodies to a pathogen. Any kind of test on a body fluid which issuitable for this type of test unit can be used. The present inventionis not specific to any type or form of test material, whether of lateralflow type or otherwise. Similarly, it is not constrained to blood, butcould be applied to tests on any suitable bodily fluid, for exampleurine, interstitial fluid, faeces, or sputum, whether directly appliedto the test unit or after pre-processing. The present invention may beapplied also to other chemical and biochemical tests, for example inindustrial, laboratory or other applications.

It will be appreciated that the specific dimensions, shapes andparameters will need to be determined, in part by trial and error, forspecific applications. The required volume of fluid will determine thesize of the fluid reservoir. The properties of the specific fluid, andthe required rate of flow will determine the size and nature of theoutlets required in the well. The surface properties of the interactionbetween the specific fluid and the materials over which it will flowalso need to be considered. For example, in an aqueous fluid, given therelatively high surface tension, smooth shapes are preferred overcorners to ensure a smooth flow of the fluid. The well 50 illustrated iscontained wholly within the test unit, however, it will be appreciatedthat this could be partly open if desired. The required flow rate andvolume are specific to the particular test material being used, and willgenerally be advised by the test material manufacturer.

FIG. 8 illustrates one form of package 40 according to the presentinvention. It includes reservoir 43, containing test fluid 41, connectedby conduit 52 to well 50. In FIG. 8 , the package 40 is filled with testfluid. As can be seen in the sectional view, there is little or no airwithin reservoir 43. Frangible seal 55 provides a seal for reservoir 43,until such time as fluid release is required.

FIG. 9 illustrates the device of FIG. 8 , after the test fluid 41 hasbeen discharged into the well 50. Hence, reservoir 43 has now beensubstantially emptied. Force applied to reservoir 43 has raised thepressure in the test fluid 41 so that frangible seal 55 has failed, andtest fluid 41 has passed through conduit 52 into well 50. Fluid 41 isthen discharged at a controlled rate from well 50, as can be seen fromthe arrows in FIG. 9 . It is noted that for clarity, the perspectiveview is upside down relative to the sectional view.

FIG. 10 illustrates only the package 40 and well 50, relative to teststrip 60. The direct engagement of well 50 with test strip ensures thattest fluid 41 is discharged onto the required location 61, with aminimal risk of fluid loss.

FIG. 11 illustrates the components of a package prior to assemblyaccording to one implementation of the present invention. The emptyblank parts to form the upper seal 117 and body 110 of the package areshown. Prior to sealing, the reservoir recess 101 must be filled withthe required test fluid 41 (not shown in this and following views forclarity). The well structure 102 and vent opening 111 are also visible.

It will be understood that the sachet or reservoir may be provided usingany suitable technology. However, the following discussion relates toformation of package 40 using a heat sealing approach using multilayermaterials.

The package may be formed from any suitable material. It will beappreciated that the material must be compatible with the fluid, and beinert with respect to the fluid. A heat sealed foil polymer ispreferred. The polymer provides heat sealing, and the foil layer assistswith protection and conservation of the fluid. It will be appreciatedthat in the present application fluid volumes are small, and highimpermeability of the packaging is important for shelf life andretention of appropriate fluid properties.

For aqueous buffer solutions, a suitable material for the top seal is apeelable foil laminate, product code RFA 037, available commerciallyfrom Amcor Flexibles. This is a heat sealable material with layers ofPET, adhesive, aluminium, and polyethylene. The material has a nominalthickness of about 60 μm.

A suitable material for the base (reservoir and well) is a cold formablelaminate Formpak 3-ply, product code 13355, available from AmcorFlexibles. This is a cold formable material with layers of aluminium,OPA and PE, with a nominal thickness of about 100 μm.

The following discussion relates particularly to the application of thepresent invention to packages containing a small fluid volume, typicallyin the range of about 50 to 250 μl, and typically about 200 μl.

In general terms, the preferred manufacturing process is to form theupper seal 117 and body 110 from suitable material, then to heat sealthem together, and form the frangible seal 121 by a secondary heatsealed section. It has been determined that it is impractical to do thisusing a single process. The frangible seal must have a well-controlledstrength. The preferred material for the body 110 includes a foil layer,which has been found to conduct heat beyond the desired confines of theseal. As a result, this approach does not produce a well formed seal.

The inventors have adopted a preferred two stage manufacturing process.In this process, a perimeter seal is first formed, identified as 120 inFIG. 12 . This does not seal the frangible seal, but rather the externalperiphery of the package 110. As can be more clearly seen in FIG. 13 ,region 103, which will form the fluid conduit and seal in the finishedproduct, are not sealed. In a second stage, a relatively narrowsecondary seal 121 is formed, as illustrated in FIG. 14 .

A further aspect has been identified by the inventors. Even in the twostage process, there is possible heat transfer through the foil, so thatsome degree of sealing occurs in the conduit region. This is largelybecause it is very narrow, and the distance from the heated tool to thearea which is not desired for sealing in the first stage is small. It isimportant that heat transfer is prevented between the top and bottomlayers in the first stage in order to achieve a reliable seal in thesecond stage. If the conduit area is sealed in the first stage, thequality of the seal and its parameters cannot be properly controlled,and hence the burst force of the seal cannot be reliably controlled orpredicted. This is addressed by two separate improvements.

It will be appreciated that a seal can only be created between the topand bottom layers if they are in contact, and heated. Heat causesactivation of the sealing layer, in this example a PE layer, and thuspotentially creates an uncontrolled seal.

In one aspect, the conduit area is formed with a larger curvature, sothat the surfaces around the conduit are not in contact and so lessliable to unwanted heat transfer which may cause sealing of the conduitarea. It will be understood that in alternative designs, themodifications to the shape of the conduit could be to the seal, body, orboth.

In a second aspect, the tool is formed not merely with an opening aroundthe conduit part, but with an open section, so as to further reduce theunwanted heat transferred by conduction or radiation to the conduitsection to eliminate any sealing of the conduit area. This cooperateswith the physical gap between the layers created by the first aspect, toeffectively remove the possibility of heat transfer while the layers arein contact, and hence prevents sealing of the conduit in the firststage.

This can be seen in FIG. 15 . It will be appreciated that the externaldimensions of the tool will be dictated by the machine with which it isdesigned to be used, and so these are shown purely in a schematic way.It will further be appreciated that while a single cavity is shown,multi-cavity tools may be used following the general principlesoutlined.

The components of package 110 (the seal is not readily visible, but isof course present) are positioned so that upper tool 130 and power tool131 are able to be moved into an operative position, generally abuttingthe package 110. It can be seen that the upper tool includes a recess132 which defines the non-sealed area, and that this recess is open 134at the top. A similar arrangement is present in recess 133 in lower tool131. Thus, these tools cooperate to move into contact, heat the materialof the package components, and produce a seal such as is shown in FIGS.12 and 13 . That is, the frangible seal 121 has not been formed.

FIG. 16 illustrates the second stage in manufacture of the packageaccording to this implementation. Upper tool 140 and lower tool 141include respective blade type portions 142, 143. When there are movedinto position, they form a relatively narrow seal by heat sealing therespective portions of the package, so as to provide frangible seal 121.

It will be appreciated that while the package, and its sub-components,have been illustrated having a particular shape which is operable withthe mechanical systems described, for different systems and applicationsit would be expected that the shapes, volumes, sizes, and so forth wouldvary to suit the particular actuation arrangements for the package.

FIGS. 18A, 18B and 18C illustrate the stages of sealing discussed above,using a longitudinal cross-section. In FIG. 18B, the reservoir 40 andwell 50 can be seen, before fluid is added to reservoir 41. A dischargeconduit 52 is defined between layers 52A, 52B, which as discussed abovein use will facilitate fluid transfer to well 50.

In FIG. 18B, fluid has been added, and the peripheral seal has beencompleted, but conduit 52 remains open and the surfaces 52A and 52Bremain separated. In FIG. 18C, frangible seal 55 has been formed by theblades 142, 143 (not visible in this view). Thus, the layers 52A, 52Bare forced together and the seal formed as part of the same processstep.

This implementation accordingly allows for the rate of delivery of atest fluid to be closely controlled. The fluid is first released intothe well. The size, number, and shape of the outlets, as well as theshape of the well, will determine the rate (whether variable orconstant) at which the fluid is released. The interaction with the restof the package, the pressure applied by the depressible portion, and theoverall fluid flow path will influence the flow rate. For example, ifthe outlets are relatively small, the fluid will be released over alonger time period. The combination of controlling the volume of thefluid, and its fluid path, allows for relatively accurate control of thedelivery of the fluid, and further ensures that it is delivered to thecorrect point on the test material.

The present invention may be implemented in ways that do not incorporateall of the preferred features noted in relation to the implementationabove. The various aspects of the invention described have advantageswithout incorporating all the components of the describedimplementations. For instance, the sample of blood or other fluid couldbe placed directly into a suitable recess or opening in the test unit,without using the sample delivery arm or another mechanism. The packagemay be inserted by a user into the test unit rather than being integral.

It will be understood that the illustrative embodiments are onlyprovided by way of example, and many other structures could be used toimplement the invention. For example, the package described could beutilised with different mechanical structures than those described, andused for completely different applications to those discussed.

What is claimed is:
 1. A liquid package, comprising: a base component; areservoir body, the reservoir body being heat sealed to the basecomponent using a set of first tools to provide a reservoir; and a fluidconduit having a frangible seal to prevent egress of fluid from thereservoir and through the fluid conduit, the frangible seal beingcreated from heat applied by a separate set of second tools across thefluid conduit.
 2. The liquid package of claim 1, wherein the liquidpackage is configured to allow liquid to be discharged through thefrangible seal when a sufficient force is applied to the reservoir. 3.The liquid package of claim 2, further comprising a discharge vessel atone end of the fluid conduit, the liquid being discharged into thedischarge vessel.
 4. The liquid package of claim 3, wherein the deliveryvessel includes at least one outlet and is shaped and configured todeliver a controlled delivery of liquid through said outlet.
 5. Theliquid package of claim 1, wherein the liquid package is adapted todeliver a test fluid for use in a test.
 6. The liquid package of claim5, wherein the liquid package is adapted for use in a test unit, theliquid being discharged by a force applied by operation of the test unitso that the test fluid is delivered to a test component within the testunit.
 7. The liquid package of claim 5, wherein the test is a medicaltest carried out on a bodily fluid or material.